Many patients have circulating antibodies to analytes of clinical interest. Conventional sandwich immunoassays, which include two or more analyte-specific antibodies, are subject to interference from analyte-reactive endogenous antibodies (e.g., autoantibodies). For example, when the assay antibodies and the endogenous antibodies bind to the same or overlapping regions of the analyte, the endogenous antibodies will compete for binding with the endogenous antibodies, leading to erroneously low results. This interference by endogenous antibodies can produce false negative results, such that individuals at risk for, or suffering from, a particular disease fail to be diagnosed.
In view of the importance of accurate detection of analytes of clinical interest, there clearly remains a need for assays, methods, and kits, and components thereof which avoid, minimize or overcome interference by endogenous antibodies.
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